The Recall Desk

Hazard

Mis Labeling recalls

9,611 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
9,611
Critical
161
Severe
589
Most recent
2026-09-24

Of the 9,611 mis labeling recalls we have scored against our rubric, 161 (2%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 589 (6%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all mis labeling recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

8501–8525 of 9611

  • HighFDA (Food)·F-1817-2013·2013-08-28

    Pacific Pure Aid Fried Onion Powder Recalled for Gluten Mislabeling

    Pacific Pure Aid is recalling Fried Onion Powder sold as gluten-free because it contains gluten. The product was distributed in five US states and five foreign countries.

    Product
    Fried Onion Powder 44.092 lb carton
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2007-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations. The issue persists despite a previous 2012 recall.

    Product
    00595201201 Femur CR-FLEX POR FEM B-L Rx, Sterile; 00595201202 Femur CR-FLEX POR FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2029-2013·2013-08-28

    Zimmer NexGen Knee Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen Cruciate Retaining knee components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; 90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2015-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations, mixing micro and standard parts.

    Product
    00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in tot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1980-2013·2013-08-28

    Invacare Recalls CHAMPION Medical Recliners Due to Heat and Labeling Issues

    Invacare is recalling 285 CHAMPION Medical Recliners because the seat pad may reach elevated temperatures and the cord set labeling is incorrect.

    Product
    CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrapped in a blanket if delivered in person. Recliner provides heat and massage after surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1818-2013·2013-08-28

    Pacific Pure Aid Thai Chili Flake Recalled for Gluten Mislabeling

    Pacific Pure Aid is recalling Thai Chili Flake sold as gluten-free because it contains gluten. The product was distributed in several US states and foreign countries.

    Product
    Thai Chili Flake
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1825-2013·2013-08-28

    NuGo Free Dark Chocolate Crunch Recalled for Undeclared Milk

    NuGo Nutrition HQ is recalling NuGo Free Dark Chocolate Crunch bars because they may contain undeclared milk, posing a risk to consumers with milk allergies.

    Product
    NuGo Free Dark Chocolate Crunch, 1.59 oz (45g) Non-Dairy
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE Y
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.

    Product
    90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1998-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1845-2013·2013-08-28

    Green Core Recalls Okami Lobster Rolls Due to Raw Meat Misbranding

    Green Core is recalling Okami Fully Cooked Wild-Caught Lobster Rolls because raw lobster meat was used instead of cooked meat.

    Product
    Okami Fully Cooked Wild-Caught Lobster Roll with Avocado, in a 7oz plastic tray with lid, to be stored less than or equal to 40 degrees F.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-1996-2013·2013-08-28

    Smith & Nephew Recalls Genesis II Knee Trial Inserts Due to Color Error

    Smith & Nephew is recalling nine Genesis II Cruciate Retaining Articular Insert trial units because they were produced with the wrong color material.

    Product
    GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-916-2013·2013-08-28

    Medicis Recalls CLENZIderm Pore Therapy Due to CLENZIderm Cleanser Mislabeling

    Medicis Pharmaceutical Corp is recalling CLENZIderm M.D. Pore Therapy kits because some bottles were incorrectly filled with Daily Foam Cleanser. The recall covers specific lots distributed in the US and internationally.

    Product
    CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Pero
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-910-2013·2013-08-28

    Novartis Recalls Maalox Nighttime Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-905-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number and/or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1991-2013·2013-08-28

    ConvaTec Flexi-Seal Signal Plus Recalled for Packaging Labeling Error

    Convatec Inc. is recalling 22,896 units of Flexi-Seal Signal Plus due to a manufacturing irregularity where lot numbers were duplicated on the packaging.

    Product
    ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-908-2013·2013-08-28

    Novartis Recalls Maalox Extra Strength Antacid Due to Illegible Labeling

    Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the packaging.

    Product
    Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-901-2013·2013-08-28

    AbbVie Recalls Mavik Trandolapril Tablets Due to Outdated Package Insert

    AbbVie is recalling 704 bottles of Mavik trandolapril tablets 4mg because they were packaged with an outdated version of the package insert.

    Product
    Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-902-2013·2013-08-28

    Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Extra Strength Antacid with Anti-Gas chewable tablets because the lot number and expiration date may be illegible on the packaging.

    Product
    Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-904-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Maalox Advanced Maximum Strength Antacid & Antigas chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle.

    Product
    Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-6
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-909-2013·2013-08-28

    Novartis Recalls Maalox Nighttime Antacid Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Maalox Nighttime Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-903-2013·2013-08-28

    Novartis Recalls Maalox Antacid Tablets Due to Illegible Packaging Labels

    Novartis Consumer Health is recalling Maalox Regular Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Miss
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-906-2013·2013-08-28

    Novartis Recalls Maalox Extra Strength Antacid Tablets Due to Illegible Labeling

    Novartis is recalling Maalox Extra Strength Antacid chewable tablets because the lot number or expiration date may be illegible on the outer plastic bottle packaging.

    Product
    Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling c
    Category
    Drug
    Distribution
    Distributed nationwide